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<p>Given that drug–excipient interactions in formulations can alter chemical properties, stability and bioavailability, thus compromising efficacy, this study focuses on assessing the compatibility between Lisinopril (LIS) and selected pharmaceutical excipients commonly employed in its formulations. LIS was characterized by powder X-ray diffraction (PXRD), Fourier-transform infrared spectroscopy (FTIR), thermogravimetric analysis (TGA) and differential scanning calorimetry (DSC). To investigate potential interactions, LIS, eight excipients, and their respective binary mixtures (1:1, w/w) were subjected to analysis by TGA, FTIR, and high-performance liquid chromatography (HPLC). A comparison between experimental and simulated TGA/DTG curves was made using Pearson correlation coefficient to determine possible chemical incompatibilities due thermal degradation. TGA results showed a probable interaction of the LIS with lactose monohydrate and mannitol. FTIR results reveal an interaction of LIS with mannitol due to fact that hydroxyl is present in it. Results from HPLC analyses have evidenced interactions found in the TG analyses, in addition to a loss of drug content corresponding to 6 and 19% in binary mixtures with lactose monohydrate and mannitol, respectively.</p>

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Characterization and study of drug–excipient compatibility of Lisinopril by TGA, FTIR and HPLC

  • 期刊论文

  • 发表日期：

    2025年9月23日

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  • Renata C. Silva,
  • Marcello G. Trevisan,
  • Jerusa S. Garcia

摘要

Given that drug–excipient interactions in formulations can alter chemical properties, stability and bioavailability, thus compromising efficacy, this study focuses on assessing the compatibility between Lisinopril (LIS) and selected pharmaceutical excipients commonly employed in its formulations. LIS was characterized by powder X-ray diffraction (PXRD), Fourier-transform infrared spectroscopy (FTIR), thermogravimetric analysis (TGA) and differential scanning calorimetry (DSC). To investigate potential interactions, LIS, eight excipients, and their respective binary mixtures (1:1, w/w) were subjected to analysis by TGA, FTIR, and high-performance liquid chromatography (HPLC). A comparison between experimental and simulated TGA/DTG curves was made using Pearson correlation coefficient to determine possible chemical incompatibilities due thermal degradation. TGA results showed a probable interaction of the LIS with lactose monohydrate and mannitol. FTIR results reveal an interaction of LIS with mannitol due to fact that hydroxyl is present in it. Results from HPLC analyses have evidenced interactions found in the TG analyses, in addition to a loss of drug content corresponding to 6 and 19% in binary mixtures with lactose monohydrate and mannitol, respectively.